1 Scope
This standard specifies the terms and definitions, requirements, test methods, inspection rules, and marks as well as instruction books of ultrasonic colour flow imaging system.
This standard is applicable to the ultrasonic colour flow imaging system (hereinafter referred to as "colour ultrasonic") with an operating frequency in the scope of 2-15MHz based on Doppler effect.
2 Normative References
The following documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments to (excluding amending error in the text), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this standard are encouraged to study whether the latest edition of these documents is applicable. For undated references, the latest edition of the normative document is applicable to this standard.
GB 9706.1-2007 Medical electrical equipment-Part 1: General Requirements for Safety (IEC 60601-1; 1988, IDT)
GB 9706.9-2008 Medical Electrical Equipment-Parts 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment (IEC 60601-2-37: 2001, IDT)
GB 9706.15-2008 Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems (IEC 60601-1-1: 2000, IDT)
GB 10152-2009 B Mode Ultrasonic Diagnostic Equipment
GB/T 14710-2009 Environmental Requirement and Test Methods for Medical Electrical Equipment
GB/T 16540-1996 Acoustics-Measurement and Characterisation of Ultrasonic Fields in the Frequency Range 0.5mhz to 15mhz-Hydrophone Method (eqv IEC 61102; 1991)
YY/T 0458-2003 Technical Requirements for Ultrasonically Blood-mimicking Doppler Phantom (IEC 61685: 2001, MOD)
3 Terms and Definitions
The terms and definitions established by GB/T 16540 and YY/T 0458 as well as the following terms and definitions are applicable to for this standard.
3.1
Doppler angle
It refers to the included angle between the ultrasonic beam axis along the propagation direction and the motion direction of scatterer or reflector.
3.2
Colour flow imaging (colour Doppler)
It is a method that adopts Doppler and autocorrelation technology to image the flow and composite the colour coding information onto the gray scale image in mode B so as to achieve real time display, which is usually referred as colour Doppler.
3.3
Spectral Doppler
It is a technology that adopts ultrasonic Doppler's principle to obtain the information such as flow direction and flow velocity and then display it by spectrum-time or flow velocity-time method after treatment.
The spectral Doppler is divided into impulse wave Doppler and continuous wave Doppler.
3.4
Penetration depth of Doppler
It refers to the maximum depth for the signal of Doppler flow detection for tissue-mimicking materials of Doppler phantom, and the signal is not able to be detected if exceeding the depth.
Note: the Doppler flow signal detected by colour ultrasonic may be expressed in three ways, namely, colour flow image, spectrogram and audio frequency output.
3.5
Error of flow velocity
It refers to the relative error of the scatterer (reflector) velocity against its set value measured from phantom or test piece by colour ultrasonic.
3.6
Accuracy of Doppler sample volume cursor
It refers to the deviation of the sampling line location of the maximum flow velocity value obtained on the cross section image of the flow phantom-mimicking pipeline compared to the center of the flow-mimicking image in the mode of the combined operation gray scale imaging-spectral Doppler.
Foreword I
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements
5 Test Method
6 Inspection Rules
7 Marks and Operation Instruction
Appendix A (Informative) Flow-mimicking Phantom and Test Piece with Chord Line
Appendix B (Informative) Measurement and Publishing of Maximum and Minimum Detectable Flow Velocity
